In late 2025, China’s regulatory landscape for pharmaceuticals changed rapidly due to a number of policies that indicate the government’s commitment to increasing innovation while ensuring adequate oversight and compliance. Recent reforms issued by the NMPA, the State Council, and the National Healthcare Security Administration (NHSA) have introduced new regulatory pathways for drug development, commercialization of new technological advances, and post-market surveillance.
Expedited IND Approval for Innovative Drugs
In September 2025, the NMPA issued a new 30-day IND submission process, supplementing the existing 60-day IND process established in 2019. Products eligible for this expedited review include innovative small molecule drug products, or Category I products (antibodies, therapeutic proteins, gene-based products, etc., that have not been previously registered or sold within China), and traditional Chinese medicines.
Eligibility for the 30-day IND review process is limited to therapeutic areas with the highest level of unmet medical needs as defined by the NMPA. These include Oncology, Cardiovascular and Cerebrovascular Disease, and Metabolic Disorders. The NMPA also requires that clinical trials be initiated by the sponsor within 3 months of the IND being granted. The NMPA will also require the Principal Investigator to develop and implement a comprehensive Risk Management Plan specific to China with respect to safety and data compliance.
The NMPA’s 30-day IND review process is built on the results from a one-year pilot program in various large cities across China. Ultimately, the goal of this initiative is to expedite and improve patient access to innovative therapies.
New Approval Framework for Biomedical Technologies
China’s State Council instituted the Regulations on the Administration of Clinical Study and Clinical Translation and Application of New Biomedical Technologies in October 2025. These regulations serve as China’s first comprehensive set of regulations governing state-of-the-art biomedical technologies like gene editing, CAR-T, NK cell therapy, and stem cell therapy. The regulation becomes effective on May 1st, 2026.
In accordance with this regulation, the approval model of research-stage biomedical technologies will shift to a filing-based process. After an ethical review and an academic review, studies can be filed with the relevant authorities. This will create fewer bureaucratic hurdles for biomedical researchers, enabling them to complete their studies more quickly. The National Health Commission (NHC) retains the supervisory authority over biomedical technologies and may intervene if safety or ethical issues arise.
Once a technology is ready to be applied clinically, it must undergo a formal approval procedure to demonstrate its safety and effectiveness before it can be adopted by hospitals. This regulation establishes a unique commercialization route for the latest biomedical technologies, distinct from the traditional approval systems.
Revision of Good Clinical Practice (GCP)
To help ensure both quality and patient safety in clinical trials, the NMPA issued a draft revision for Good Clinical Practice (GCP) for Drugs in October 2025. As part of this proposed revision, the eight existing chapters have been consolidated down to six. There will now be a chapter specifically on Data Governance, and there will be clear lines of accountability assigned to both the sponsor (who retains overall responsibility) and Principal Investigators (who act as site-level point of contact).
The draft demonstrates continuing efforts by China to align itself with international standards for clinical trial oversight, including risk-based oversight, Quality by Design (QbD), and proportionate risk management.
Key changes include the annual review by the ethics committees, increased protections for vulnerable populations, specific requirements for managing investigational products (including retaining bioequivalence samples for two years), as well as establishing clear guidelines for maintaining data integrity. Sponsors and CROs who are planning to conduct clinical studies in China should start preparing for the implementation of these changes as soon as possible.
Heightened Scrutiny of Prescribing Practices
China has intensified oversight of excessive prescribing through a new NHSA notice issued on November 3, 2025, alongside the nationwide Insurance Fraud “Hundred-Day Campaign.” The initiative targets fraud, abuse, and improper use of medical insurance funds by leveraging advanced, technology-enabled supervision.
The NHSA plans to deploy “intelligent” monitoring through the national insurance platform in three phases: pilot monitoring of 50 key drugs by the end of 2025, expansion to at least 100 drugs nationwide by mid-2026, and full national standardization by the end of 2026. Although the official drug list has not yet been released, enforcement is expected to focus on high-cost, high-utilization products commonly associated with insurance fund misuse.
Using advanced analytics and drug traceability tools, regulators will identify abnormal prescribing and procurement behavior. While the system allows leniency for self-correction, serious violations will face strict penalties. For multinational pharmaceutical companies, the initiative significantly raises compliance, audit, and reputational risks, underscoring the need for stronger internal monitoring of distribution and prescribing patterns in China.
Conclusion
These developments signal a more sophisticated regulatory environment in China. Faster approval pathways and new frameworks for advanced technologies aim to foster innovation and global competitiveness. On the other hand, tighter GCP standards, enhanced prescribing oversight, and refined procurement rules strengthen compliance and system sustainability. For pharmaceutical and biotech companies, success in China will increasingly depend on proactive compliance strategies across the entire product lifecycle.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.